Exercise Regulation of Human Adipose Tissue

Sponsor

Joslin Diabetes Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03133156

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

71.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.

Condition or Disease	Intervention/Treatment	Phase
Healthy Obese Diabetes Mellitus, Type 2	Other: Exercise Intervention	N/A

Detailed Description

The prevalence of obesity and type 2 diabetes in the United States and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. The discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. An established treatment for type 2 diabetes and obesity is endurance exercise training. Exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. Moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. The study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Exercise Regulation of Human Adipose Tissue

Actual Study Start Date :

Jun 15, 2017

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Intensity Training-Healthy Lean Eligible subjects will undergo a 10-week moderate intensity exercise program.	Other: Exercise Intervention 10-Week Aerobic Exercise Training
Experimental: Moderate Intensity Training-Healthy Overweight/Obese Eligible subjects will undergo a 10-week moderate intensity exercise program.	Other: Exercise Intervention 10-Week Aerobic Exercise Training
Experimental: Moderate Intensity Training-Overweight/Obese Type 2 Diabetes Eligible subjects will undergo a 10-week moderate intensity exercise program.	Other: Exercise Intervention 10-Week Aerobic Exercise Training
Experimental: High Intensity Training-Healthy Lean. Eligible subjects will undergo a 10-week high intensity exercise program	Other: Exercise Intervention 10-Week Aerobic Exercise Training

Outcome Measures

Primary Outcome Measures

Changes in human adipose tissue characteristics following exercise training. [Change from baseline adipose tissue characteristics following 10 weeks of exercise training.]
Effects of exercise training on adipose tissue in humans.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age: 25-55 years old at the time of screening
Body mass index (BMI) must be:
≥20 and ≤ 27 kg/m2 for lean subjects
≥25 and ≤ 37 kg/m2 for subjects with type 2 diabetes
≥27 and ≤ 37 kg/m2 for obese/overweight subjects
HbA1c values:
≤5.7 ± 0.1% for lean and overweight/obese subjects
6.5 ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes

Exclusion Criteria:

Age <25 and >55 years old
Type 1 Diabetes
HbA1c ≥ 9.0%
Heart or lung disease
Basal-Bolus Insulin regimen
Use of beta-blockers or thiazolidinediones
Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
BMI ≥ 37 kg/m2
Current dieting or weight loss efforts
Current pregnant or breastfeeding
Known history of HIV/AIDS or certain cancers
Biochemical evidence of renal or hepatic dysfunction; renal or liver disease
Demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
Recent blood donation
Clinical history of stroke
Severe hypertension (systolic > 160 mmHg or diastolic > 90 mmHg)
Inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
Participants who screen positive for The American Heart Association's contraindications to exercise testing
History of keloid formation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Joslin Diabetes Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Laurie J Goodyear, PhD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joslin Diabetes Center

ClinicalTrials.gov Identifier:

NCT03133156

Other Study ID Numbers:

2016-33
R01DK112283

First Posted:

Apr 28, 2017

Last Update Posted:

Jan 6, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joslin Diabetes Center

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 6, 2022